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The Dose-Response Effect of Exercise Training in Patients With Type 2 Diabetes

This study is currently recruiting participants.
Verified July 2011 by University of Central Arkansas
Sponsor:
Information provided by:
University of Central Arkansas
ClinicalTrials.gov Identifier:
NCT01417845
First received: August 11, 2011
Last updated: October 20, 2011
Last verified: July 2011
History of Changes
  Purpose

The purpose of this randomized clinical trial is to compare the dose-response effect of moderate versus high doses of exercise training on acute exercise-induced glucose changes, physical fitness, and physical function in patients with type 2 diabetes. The research hypothesis is that a high dose of exercise training will be superior to a moderate dose on such outcomes in individuals with type 2 diabetes.


Condition Intervention
Type 2 Diabetes
 Behavioral: High Dose of Exercise Training
Behavioral: Moderate Dose of Exercise Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Dose-Response Effect of Exercise Training on Acute Exercise-Induced Glucose Changes, Physical Fitness, and Physical Function in Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Central Arkansas:

Primary Outcome Measures:
  • Acute Exercise-Induced Glucose Changes [ Time Frame: Baseline, after about 45 minutes of exercise training, and 1 hour after about 45 minutes of exercise training ] [ Designated as safety issue: No ]
  • Physical Fitness [ Time Frame: Baseline and 3 months thereafter ] [ Designated as safety issue: No ]
  • Physical Function [ Time Frame: Baseline and 3 months thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence [ Time Frame: Baseline and 3 months thereafter ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Baseline and 3 months thereafter ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2011
Arms Assigned Interventions
Experimental: High Dose
High dose of combined resistance and aerobic training
 Behavioral: High Dose of Exercise Training
  • High dose of combined resistance and aerobic training
  • Resistance training is performed 2 days per week for 3 months
  • Aerobic training is performed on the same days as resistance training and 1 additional day per week.
Active Comparator: Moderate Dose
Moderate dose of combined resistance and aerobic training
 Behavioral: Moderate Dose of Exercise Training
  • Moderate dose of combined resistance and aerobic training
  • Resistance training is performed on 2 days per week for 3 months.
  • Aerobic training is performed on the same days as resistance training and 1 additional day per week.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All participants meet the American Diabetes Association diagnostic criteria for type 2 diabetes.
  • A physician must consider each participant to be medically stable to participate in this investigation.

Exclusion Criteria:

  • Any individual with a history of a medical condition identified by the American Heart Association as an absolute contraindication to exercise testing is excluded from this study.
  • Any individual with angina (stable or unstable), uncontrolled hypertension, proliferative retinopathy, severe peripheral neuropathy, nephropathy, autonomic neuropathy, history of coronary artery disease, history of myocardial infarction, or unable to participate in this study due to a physical impairment is excluded from this investigation.
  • Any individual involved in resistance training or aerobic training within 3 months of the beginning of this investigation is excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417845

Contacts
Contact: James D Taylor, PhD, PT 501-450-5545 dtaylor@uca.edu

Locations
United States, Arkansas
University of Central Arkansas Recruiting
Conway, Arkansas, United States, 72035
Contact: James D Taylor, PhD, PT     501-450-5545     dtaylor@uca.edu    
Principal Investigator: James D Taylor, PhD, PT            
Sponsors and Collaborators
University of Central Arkansas
Investigators
Principal Investigator: James D Taylor, PhD, PT University of Central Arkansas
  More Information

No publications provided

Responsible Party: Principal Investigator: J. David Taylor, PhD, PT, University of Central Arkansas
ClinicalTrials.gov Identifier: NCT01417845     History of Changes
Other Study ID Numbers: UCA-IRB-11-077
Study First Received: August 11, 2011
Last Updated: October 20, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013